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Trial record 32 of 226 for:    warfarin AND International

Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT01178853
Recruitment Status : Completed
First Posted : August 10, 2010
Results First Posted : October 8, 2012
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):
Kowa Research Institute, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Warfarin
Drug: Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
Drug: Warfarin 5 mg + Pitavastatin 4mg once daily (QD)
Enrollment 48
Recruitment Details 14 July 2010 – 09 November 2010
Pre-assignment Details  
Arm/Group Title Pitavastatin/Rosuvastatin Rosuvastatin/Pitavastatin
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Period 1 (Warfarin Titration)
Started 24 24
Completed 23 22
Not Completed 1 2
Reason Not Completed
INR Out of Range             1             2
Period Title: Period 2 (Warfarin + Study Drug)
Started 23 22
Completed 22 22
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Period Title: Period 3 (Warfarin Titration)
Started 22 22
Completed 21 22
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Period 4 (Warfarin + Study Drug)
Started 21 22
Completed 21 19
Not Completed 0 3
Reason Not Completed
Adverse Event             0             2
Withdrawal by Subject             0             1
Arm/Group Title Pitavastatin/Rosuvastatin Rosuvastatin/Pitavastatin Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
 100.0%
24
 100.0%
48
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 48 participants
32.4  (7.8) 34.1  (7.2) 33.3  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
8
  33.3%
8
  33.3%
16
  33.3%
Male
16
  66.7%
16
  66.7%
32
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 24 participants 48 participants
24 24 48
1.Primary Outcome
Title Percent Mean Change From Baseline of International Normalized Ratio (INR)
Hide Description INR is the ratio of a patient's prothrombin time to a standard, raised to the power of the ISI value for the tissue factor reagent used (INR = (PT-Test/PT-Normal)^ISI)
Time Frame 22 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin + Pitavastatin Warfarin + Rosuvastatin
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 42 43
Mean (Standard Deviation)
Unit of Measure: percent change
0.0452  (2.61) 0.1605  (9.43)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Warfarin + Pitavastatin Warfarin + Rosuvastatin
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Warfarin + Pitavastatin Warfarin + Rosuvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Warfarin + Pitavastatin Warfarin + Rosuvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   0/42 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Warfarin + Pitavastatin Warfarin + Rosuvastatin
Affected / at Risk (%) Affected / at Risk (%)
Total   6/42 (14.29%)   3/43 (6.98%) 
Gastrointestinal disorders     
Nausea  3/42 (7.14%)  3/43 (6.98%) 
Nervous system disorders     
Headache  3/42 (7.14%)  0/43 (0.00%) 
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
May not publish
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roger Morgan, MD, FACS
Organization: Kowa Research Institute, Inc.
Phone: 919-433-1600
EMail: RMorgan@KowaUS.com
Layout table for additonal information
Responsible Party: Kowa Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01178853     History of Changes
Other Study ID Numbers: NK-104-4.03US
First Submitted: August 9, 2010
First Posted: August 10, 2010
Results First Submitted: March 29, 2012
Results First Posted: October 8, 2012
Last Update Posted: October 8, 2012